Teva Mgr Regulatory Affairs 

Mexico, Mexico City, Mexico City 

914202981

The Regulatory Affairs Manager will ensure compliance with national and international regulations, managing submissions and keeping product records up to date throughout the product's life cycle.

• Manage the regulatory submissions to local authorities (new applications, lifecycle management, licenses, GMPs).
• Guarantee compliance with applicable national and international regulations.
• Review regulatory changes assessing their impact on company operations and train the applicable areas.
• Monitor responses to regulatory inquiries and resolve pending issues.
• Keep update internal databases and applicable software to perform regulatory tracking and intelligence reports.

Required Education: Bachelor's degree in QFB, QFI, IQ, LQ or related career, preferably with a higher academic degree.
Experience: Minimum 3 years in similar position in regulatory affairs or related field.
General knowledge in Quality Management Systems, management skills, training as an auditor.
Specific knowledge of national and international regulatory standards (ICH) applicable to the pharmaceutical industry (LGS, RIS, NOM, etc.), Food Supplements, Medical Devices and Cosmetics.

Sr Mgr Regulatory Affairs

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